Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients
- Conditions
- Liver Steatoses
- Interventions
- Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurements
- Registration Number
- NCT06443723
- Lead Sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Brief Summary
The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.
- Detailed Description
Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.
This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- who were found to have undergone cholecystectomy at least five years ago,
- who could feed orally and perform activities of daily living
- participants who had not undergone cholecystectomy with similar characteristics were included in the study
- those with chronic liver disease
- malignancy or history of malignancy
- in a chemotherapy program
- with active infection
- any organ failure
- pregnancy
- use of drugs that cause steatosis in the liver
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control USG, blood tests, waist, hip, height and blood pressure measurements Evaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters. cholecystectomy USG, blood tests, waist, hip, height and blood pressure measurements Evaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.
- Primary Outcome Measures
Name Time Method definition of overweight through study completion, an average of 4 months BMI \>25 kg/m2
diabetes mellitus through study completion, an average of 4 months fasting plasma glucose \>126mg/dL
HDL-cholesterol levels through study completion, an average of 4 months \<40 mg/dL for males and \<50 mg/dL for females.
Definition of pre-diabetes through study completion, an average of 4 months fasting plasma glucose of 100-125 mg/dL
Diagnosis of MAFLD through study completion, an average of 4 months hepatic steatosis + (diabetes mellitus and/or overweight and/or metabolic dysfunction) metabolic dysfunction is defined as the presence of at least two criteria(Pre-diabetes, TG, HDL, blood pressure, waist circumference)
Upper limits of waist circumference through study completion, an average of 4 months ≥102 cm in men and 88 cm in women
Triglyceride levels through study completion, an average of 4 months ≥1.70 mmol/L
Blood pressure upper limit through study completion, an average of 4 months ≥130/85 mmHg
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
🇹🇷Ankara, Turkey